REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)

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This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.




Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment. Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver. Patient is able to tolerate antiplatelet therapy

Type of Study



Harmony Campus
Medical Center of the Rockies

Principal Investigator
Photograph of Justin Strote,  MD

Justin Strote, MD

Study ID

Protocol Number: 19-6030

More information available at NCT03821129

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